Kornimate/medical-research-clean huggingface dataset:
the diabetes transition study for young people aged between 16-20 years of age.

Conditions: Type 1 Diabetes Mellitus

Summary: study into the use of a diabetes specialist transition nurse in the care of young people aged 16-20 years, with type 1 diabetes; undergoing transition from the paediatric to the adult diabetes services at the northampton general hospital

does the use of a structured diabetes transition program in the care of young people transitioning from the paediatric to the adult diabetes services at northampton general hospital improve the study group mean hba1c, reduce the number of diabetes related hospital episodes and increase attendance at the adult diabetes clinic following transition to the adult service?

Eligibility criteria:
inclusion criteria: * established type 1 diabetes for minimum of 1 year * attended the northampton general hospital, children's and young peoples diabetes service for at least 6 months prior to transition * between the ages of 16 - 20 years * ability to participate in all aspects of the trial * written informed consent must be obtained exclusion criteria: * any condition which may interfere with the subjects ability to participate in the study including cystic-fibrosis related diabetes * subjects who move away from the northampton general hospital clinic during the transition process * those unable to give informed consent
evaluation of the cook biodesign® nipple reconstruction cylinder (nrc)

Conditions: Breast Cancer; Breast Reconstruction; Nipple Reconstruction

Summary: patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the cook biodesign® nipple reconstruction cylinder.


Eligibility criteria:
inclusion criteria: * patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction. * patient presents with a desire to obtain nipple reconstruction * patient is at least 18 years of age * and other inclusion criteria exclusion criteria: * patient is not medically fit enough for surgery under local anesthesia * patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray) * patient is pregnant, breastfeeding or planning further pregnancy during the study period * patient has physical allergies or cultural objections to the receipt of porcine products * and other exclusion criteria

Keywords: biodesign nipple reconstruction breast cancer mastectomy
prevention of alcohol related incidents in the us air force

Conditions: Alcohol Abuse

Summary: alcohol misuse poses significant public health concerns in the u.s. military. a brief alcohol intervention (bai) have been shown to reduce alcohol related incidents among airmen undergoing training. the current study sought to examine whether a booster bai administered at the end of an airmen's training reduced alcohol related incidents out to a one-year follow-up. participants were 26,231 us air force technical trainees recruited between march 2016 and july 2018. participants were cluster randomized by cohort to two conditions: bai + bai booster or bai + bystander intervention. the primary analysis was a comparison of the interventions' efficacies in preventing article 15 alcohol related incidents at a one-year follow-up, conducted using a generalized estimating equations logistic regression model controlling for covariates.


Eligibility criteria:
participants were airmen undergoing technical training at five military bases (lackland air force base, keesler air force base, sheppard air force base, goodfellow air force base and fort sam houston) in texas and mississippi from march 2016 through july 2018. eligibility criteria included being at least 18 years of age and understanding the consent process in english.

Keywords: prevention alcohol abuse
active drug comparative, multi-center, phase3 clinical study to evaluate the efficacy and safety of pg201 in osteoarthritis patients

Conditions: Osteoarthritis of the Knee

Summary: the objective of this study was to to evaluate the efficacy and safety of pg201 in osteoarthritis patients. this clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. type 2 error (β) was set as 0.2, and the power of the test was set as 80%. assuming 20% drop-out rate, the number of subjects required for each treatment group was estimated to be 154, while the total number of subjects required for the study 308. non-inferiority margin: 8mm

patients in the pg201 group were prescribed two pg201 tablets per day(bid) and one celecoxib placebo capsule each in the morning and evening per day for 8 weeks. patients in the celecoxib group were prescribed celecoxib 200 mg (one 200 mg capsule and one celecoxib placebo capsule) and one pg201 placebo tablet each in the morning and evening per day for 8 weeks.

Eligibility criteria:
inclusion criteria: 1. patients ≥40 and ≤ 80years of age. 2. patients who meet the american college of rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow: a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings. * age\> 50 years. * morning stiffness for less than 30 minutes. * crepitus during movement of the weight-bearing knee. 3. patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening. 4. patients who received nonsteroidal antiinflammatory drugs (nsaids)/cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening. 5. patients who had a score of 100mm pain vas ≤80 mm at screening. 6. patients who had a score of 100mm pain vas ≥50 mm at baseline. 7. patients should be able and willing to provide the written informed consent. exclusion criteria: 1. patients with a history of surgery or arthroscopy of the study joint within the previous 6 months. 2. patients with trauma of study joint within the previous 12 months. 3. patients with symptomatic hip osteoarthritis, other condition that would interfere with study assessments. 4. patients with any other type of arthritis, active malignancies or any active gi, cardiovascular, renal, hepatic, neurologic, or psychiatric disease. 5. patients with a known hypersensitivity or intolerance to nonsteroidal antiinflammatory drugs (nsaids), aspirin or cyclooxygenase-2 inhibitor. 6. patients with uncontrollable hypertension. 7. patients with any of creatinine, bilirubin, alanine aminotransferase or aspartate aminotransferase \> 1.5 times the upper lange of normal at screening. 8. patients with a history of drug or alcohol abuse.

Keywords: pg201 non-inferiority 100mm pain vas
expanded access program of tak-755 for congenital thrombotic thrombocytopenic purpura (cttp)

Conditions: Thrombotic Thrombocytopenic Purpura (TTP)

Summary: the expanded access program allows people to gain access to unlicensed treatment on compassionate grounds. tak-755 also known as radamts13, is a medicine that treats people born with severe congenital or hereditary thrombotic thrombocytopenic purpura (cttp). this expanded access program enables continued access to those participants who have no other treatment options available for cttp.

this is an expanded access program in which the drug being given is called tak-755. this study will provide access to tak-755 prior to marketing authorization for eligible participants with severe congenital or hereditary ttp who cannot adequately be treated via current standard of care and who cannot enter a clinical trial. all participants will receive tak-755 as intravenous (iv) injection based on their weight as measured at each dosing visit. this is a multi-center, international program. participants will continue treatment until benefit is no longer derived from the treatment (or treatment is no longer tolerable), sponsor decision, the participant chooses to discontinue the treatment, or tak-755 becomes commercially available.

Eligibility criteria:
inclusion criteria: 1. participant or legally authorized representative has provided signed informed consent (≥18 years of age) and/or assent form (signed by legal representative if participants is \<18 years of age). 2. participant has a documented diagnosis of severe congenital adamts13 deficiency, defined by: 1. confirmed molecular genetic testing, or 2. adamts13 activity and a negative test for adamts13 antibodies. 3. participant is currently on a prophylactic regimen or has a documented history of at least 1 ttp event. 4. standard of care (soc) is considered inadequate, or the participant is intolerant to soc\*. * soc are plasma-based therapies, e.g., fresh frozen plasma or s/d treated plasma exclusion criteria: 1. participant is currently eligible to enter into an interventional clinical trial for cttp. 2. there is a suitable alternative commercially available treatment for the treatment of cttp. 3. participant has been diagnosed with any other thrombotic microangiopathies (tmas) like disorder (microangiopathic hemolytic anemia), including acquired ttp. 4. participant has a known hypersensitivity/allergies/intolerance or contraindications to tak-755 or its excipients, such as hamster proteins. 5. participant has a medical history or presence of a functional adamts13 inhibitor. 6. participant has a medical history of genetic or acquired immune deficiency that would interfere with the assessment of product immunogenicity, including participants who are human immunodeficiency virus (hiv)-positive with an absolute cluster of differentiation 4 (cd4) count \<200 per millimeter cube (\<200/mm\^3) or who are receiving chronic immunosuppressive drugs

Keywords: drug therapy
evaluating the early bactericidal activity, safety and tolerability of nebulised resp301 in adults with tuberculosis

Conditions: Rifampicin Susceptible Pulmonary Tuberculosis

Summary: a phase 2, single-centre, open-label, parallel control arm, randomised clinical study to evaluate the early bactericidal activity (eba), safety and tolerability of nebulised resp301 in adults with newly diagnosed, rifampicin susceptible pulmonary tuberculosis

a total of approximately 15 participants will be recruited per treatment arm (total of approximately 75 participants in the study). control arm participants will be split across sequential stages stages 1 and 2, with no stratification. stage 1: to determine the eba of * treatment arm 1 (active; n = 15) - inhaled resp301 6 ml dosed via nebulisation administered three times daily over 14 days * treatment arm 2 (control; n= 5) - hrze taken orally once daily on completion of stage 1, recruitment will be paused and an interim analysis performed to determine whether the study should proceed to stage 2. stage 2: to determine the eba of * treatment arm 2 (control; n= 10) - hrze taken orally once daily * treatment arm 3 (active; n = 15) - inhaled resp301 6 ml dosed via nebulisation administered once daily over 14 days * treatment arm 4 (active; n = 15) - inhaled resp301 6 ml dosed via nebulisation administered twice daily over 14 days * treatment arm 5 (active; n = 15) - inhaled resp301 6 ml dosed via nebulisation administered three times daily in combination with hrze taken orally once daily over 14 days

Eligibility criteria:
inclusion criteria: * provide written, informed consent prior to all study-related procedures and agree to undergo all study procedures * body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive * newly diagnosed pulmonary tb * rifampicin susceptible pulmonary tb as determined by molecular testing * ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 ml or more) * spirometry performed during screening with a fev1 of ≥ 40% * be of non-childbearing potential or willing to use effective methods of contraception exclusion criteria: * hiv positive and cd4 \< 350 cells/mm3 or are receiving antiviral therapy (art) * methaemoglobin saturation (spmet) \>3% * female participant who is pregnant or breast-feeding * participants planning to conceive a child within the anticipated period of study participation and for at least 90 days after the last dose of imp in the study * participation in other clinical studies with investigational agents within 8 weeks prior to screening * treatment received for this episode of tb with any drug active against m.tb * treatment with immunosuppressive medications such as tnf-alpha inhibitors within 2 weeks prior to screening, or systemic corticosteroids for more than 7 days within 2 weeks prior to screening. * treatment with nitric oxide and other nitric oxide donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening

Keywords: early bactericidal activity (eba)
phase 2 - rhythmic light therapy for alzheimer's disease patients

Conditions: Mild Cognitive Impairment

Summary: participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (hz) flicker (rhythmic light \[rl\]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 hz flicker (rl); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. after a 4-week washout period, a final round of assessments will be obtained. study assessments (except for the pittsburgh sleep quality index and montreal cognitive assessment) will be collected at the end of each week, for a total of 8 assessments.

the tailored lighting intervention used to promote circadian entrainment will provide high circadian stimulation during the day produced by narrowband blue light peaking at 470 nanometers (nm). a comparison lighting intervention (i.e., placebo lighting), a narrowband red light peaking at 630 nm, will be used as a control. both the red and the blue light devices will also provide either the 40 hertz (hz) flicker (rl) or the random flicker (placebo rl). for the random flicker (placebo rl), the duty cycle will be delivered with a random interval determined by a poisson process with an average interval of 40 hertz (hz).

Eligibility criteria:
inclusion criteria: * participants must be diagnosed with mild cognitive impairment or mild alzheimer's disease, as defined by a montreal cognitive assessment score between 17 and 25; * have sleep disturbance indicated by a score \>5 on the pittsburgh sleep quality index * participants must reside in their homes, independent living, or assisted living facilities exclusion criteria: * participants taking sleep medication * residence in a skilled nursing facility or long-term care * obstructing cataracts, macular degeneration, and blindness * severe sleep apnea or restless leg syndrome * history of severe epilepsy

Keywords: light treatment circadian rhythms gamma wave entrainment rhythmic light sleep cognition
the effect of tyrosine kinase receptor axl on dialysis prognosis in chronic hemodialysis patients

Conditions: Hemodialysis Complication

Summary: the purpose of this study is to evaluate whether tyrosine kinase receptor axl affects the dialysis prognosis in chronic hemodialysis patients

it is reported that hemodialysis (hd) patients often develop chronic systemic inflammatoion, and increased inflammatory activity is associated with vascular access failure, cardiovascular disease and death in hd patients. the interaction of axl and its ligand gas6 plays an important role in modulating immune response, inhabiting toll-like receptor (tlr) signaling and suppressing inflammatory cytokines production. thus, we want to investigate the relationship between tyrosine kinase receptor axl and the dialysis prognosis in hd patients in three-years follow-up.

Eligibility criteria:
inclusion criteria: * hemodialysis for more than 6 months exclusion criteria: * patients who received warfarin therapy; * patients with chronic infectious disease or acute infection; * patients with hemodialysis inadequacy; * the age of patients is older than 65 years or younger than 18 years. * patients who can not sign an informed consent or disagree to follow up

Keywords: hemodialysis axl prognosis
cd19/bcma car-t cell therapy for refractory/relapsed lupus nephritis

Conditions: Lupus Nephritis

Summary: a clinical study of the safety and efficacy of cd19/bcma car-t cell therapy for refractory/relapsed lupus nephritis.

in this study, 9 patients with relapsed refractory lupus nephritis were proposed to undergo cd19/bcma car-t cells therapy. under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of cd19/bcma car-t cells therapy for relapsed refractory lupus nephritis; at the same time, on the basis of expanding the sample size, more safety data on cd19/bcma car-t cells treatment for relapsed refractory lupus nephritis were accumulated.

Eligibility criteria:
inclusion criteria: * 1. age ≥18 years old; * 2. a clinical diagnosis of systemic lupus erythematosus (sle) according to the 2019 american college of rheumatology (acr) and european federation of rheumatology societies (eular) /acr classification criteria. grade iii, iv, or v lupus nephritis was confirmed by biopsy according to the 2003 isn/rps standard. * 3. sledai-2k ≥8 during screening * 4. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type); * 5. expected survival \>12 weeks; * 6. fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known); * 7. volunteer to participate in this experiment and sign the informed consent. exclusion criteria: * 1. history of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; * 2. electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; * 3. active infected persons who are not cured: * 4. active hepatitis b or c virus infection; * 5. patients who have taken more than 20mg/d of prednisone or equivalent systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids); * 6. have used any gene therapy products before; * 7. insufficient amplification ability (\<5 times) in response to cd3 / cd28 costimulation signals; * 8. alt/ast\>3 times the normal amount or bilirubin \>2.0 mg/dl; * 9. those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment; * 10. hiv-infected people; * 11. any situation that the investigator believes may increase the risk to the subject or interfere with the test results.

Keywords: cd19/bcma car-t
impact of fluid management within a goal-directed hemodynamic protocol on acid-base balance in elective trauma surgery

Conditions: Hemodynamic Instability

Summary: the purpose of this study is to determine whether the administration of a compound of balanced infusion solutions including 50% crystalloid and 50% colloid has a positive impact on acid-base balance in elective hip replacement surgery. the application of the study medication will be carried out through a goal-directed intraoperative therapy by transoesophageal doppler.


Eligibility criteria:
inclusion criteria: * patients at the age of 60 and above who want to undergo an elective hip replacement surgery in the center of musculoskeletal surgery * offered patient information and written informed consent exclusion criteria: * participation in another trial according to the german drug law 30 days to and during the study * lacking willingness to save and hand out data within the study * accommodation in an institution due to an official or judicial order * (unclear) history of alcohol or substances disabuse * absent knowledge of german language * analphabetism * allergy to hydroxyethyl starch or other ingredients of the intravenous solutions * for women: pregnancy or positive pregnancy test within the preoperative screening * operation due to case of emergency, polytrauma or pathologic fracture * only use of regional anaesthesia * american society of anaesthesiologists (asa) classification greater than iii * peripheral or central edema * aids (according to the cdc-classification of hiv-infection: category c) * rheumatoid disease under treatment with anti-tnf-alpha-ab and/or high-dose-corticoid-treatment * immunosuppression therapy * history of bleeding tendency (e.g. von-willebrand-disease, thrombocytopenia) * derailed metabolic disorder (e.g. diabetes mellitus (glucose \> 300 mg/dl) during the preoperative screening) * known history of electrolyte disturbance (e.g. hyperkalemia \> 5.8 mmol/l, hypernatraemia \> 155 mmol/l) * known history of acid-base-dysbalances * history of intracranial hemorrhage within one year of participation in the study * neurological or psychiatric disease with limited contractual capability * advanced disease of the oesophagus or upper respiratory tract * operation in the area of the oesophagus or nasopharynx within the last two months * chf (congestive heart failure) according to (new york heart association) classification - nyha class iv * liver disease (child b or c cirrhosis, end-stage liver disease (meld-score greater than 10)) * conditions after acute or chronic pancreatitis * renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)

Keywords: fluid and volume management acid-base balance goal-directed therapy transoesophageal doppler